OpGen, Inc. (NASDAQ:OPGN)
Q4 2015 Earnings Conference Call
March 30, 2016 10:00 AM ET
Kim Golodetz - IR
Evan Jones - Chairman and CEO
Tim Dec - CFO
Kevin Krenitsky - President
Jason McCarthy - Maxim
Yi Chen - H.C. Wainwright
Welcome to the OpGen Financial Results Conference Call. At this time, all participants are in a listen-only. [Operator Instructions] As a reminder, this conference is being recorded today, March 30, 2016.
I would now like to turn the conference over to Ms. Kim Golodetz. Please go ahead.
Thank you. This is Kim Golodetz with LHA. Thank you all for participating in today's call.
Joining me from OpGen, Inc. are Evan Jones, Chairman and Chief Executive Officer; Tim Dec, Chief Financial Officer; and Dr. Kevin Krenitsky, President.
Earlier this morning, OpGen announced financial results for the fourth quarter of 2016. If you have not received this news release or if you would like to be added to the company's distribution list, please call LHA in New York at 212-838-3777 and speak with Carolyn Curran.
Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements regarding the operations and future results of OpGen, Inc. I encourage you to review the company's filings with the Securities and Exchange Commission including without limitation the company's forms 10-K and 10-Q which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Factors that may affect the coming's results include, but are not limited to the rate of adoption of its products and services by hospitals, the success of its commercialization efforts, the successful completion of its new product development efforts, the effect on its business of existing and new regulatory requirements and other economic and competitive factors. The content of this conference call contains time sensitive information that is accurate only as of the date of the live call, today March 30, 2016. The company undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call
With that said, I would like to turn the call over to Evan Jones. Evan?
Thank you, Kim. Good morning and welcome to the OpGen fourth quarter and year-end conference call. During 2015 we successfully transformed OpGen into a precision medicine company with the goal of helping improve antibiotic therapy and combating drug-resistant infections globally.
As we begin our prepared remarks, I want to remind all of you of the serious issues we are working to address here at OpGen. Earlier in March, the CDC issued a vital signs report highlighting the rising tissue of multidrug-resistant infections in US acute care hospitals. The report noted that one in seven catheter and surgery related hospital-acquired infections are caused by six pathogenic antibiotic-resistant bacteria. These include MRCA and what the Director of the CDC describes as nightmare bacteria CREs or carbapenem-resistant Enterobacteriaceae. The rate increases to one in four infections in long-term acute care hospitals.
Our team at OpGen is working to address this rising healthcare crisis with our precision medicine solutions. We are developing disruptive technology that combines rapid pathogen analysis and key advances in bioinformatics and data analysis to address the growing needs for rapid diagnostics, antimicrobial stewardship and hospital MDRO surveillance.
Results for the fourth quarter and fiscal 2015 reflect the success of our emerging molecular information business with solid year-over-year revenue growth and an expanding portfolio of high value molecular diagnostic products and services.
This morning Tim Dec will discuss our financial results. Kevin will review commercial and operations progress and activities and I will conclude by reviewing strategic development plans at the company. Tim?
Thank you, Evan. This morning I'll touch on the highlights of our fourth quarter financial results and summarize our 2015 performance. Starting with the fourth quarter of 2015, total revenue was $1.3 million as compared to $1.1 million for the fourth quarter of 2014. The net increase was due to the following items. Product sales and laboratory services revenue increased $800,000 or 165% quarter-over-quarter. This was due to the inclusion of our Rapid ID products from our acquisition last summer. Collaboration revenue decreased $600,000 as we completed our technology development agreement with Hitachi High-Technologies.
Gross margin from product sales and laboratory services which excludes our collaboration revenue was 57% in the fourth quarter of 2015 as compared to 47% in the fourth quarter of 2014. This increase reflects the contribution of our higher margin QuickFISH products as well as a de-emphasis on our legacy business line.
Total operating expenses in the fourth quarter of 2015 were $6.2 million as compared to $2.5 million in the fourth quarter of 2014. The quarter-over-quarter increase was due to the following items. Research and development expenses increased $1 million. This increase was due to development cost associated with the automation project for our QuickFISH product line. General and administrative expenses increased $1.4 million. This increase was due to higher public company costs, legal costs, personnel costs and stock-based compensation. Sales and marketing expenses increased $800,000. This increase was due to personnel costs associated with our recently established sales and marketing organization and pilot study costs.
The company reported an operating loss of $4.8 million for the fourth quarter of 2015 compared with an operating loss of $1.3 million for the fourth quarter of 2014. The net loss attributable to common stockholders for the fourth quarter of 2015 was $4.7 million or $0.38 per share versus the net loss attributable to common stockholders for the fourth quarter of 2014 of $1.6 million or $3.41 per share.
Turning to the full year financial results, total revenue for the 12 months ended December 31, 2015 was $3.2 million as compared to $4.1 million for the same period of 2014. The overall net decrease was as such. Product sales and laboratory services revenue, which again excludes collaboration revenue, increased $1.1 million or 65% during 2015. This was due to sales of our Rapid ID products. That increase was offset by decrease in collaboration revenue of $2.1 million or 86% as we completed our technology development agreement with Hitachi.
Our 2015 gross margin from product sales and services, which excludes collaboration revenue was consistent with our 2014 rate at 45%, reflecting the contribution of our high margin FISH products offset by charges from the start-up of our CLIA lab operation.
Total operating expenses for the 12 months ended December 31, 2015 were $18.2 million as compared to $9.7 million in the same period of 2014. The year-over-year increase was due to the following items. Research and development expenses of $6 million for 2015 compared to $4.4 million in 2014. Again, this increase was due to development costs associated with the automation project for our QuickFISH product line; general and administrative expenses of $5.8 million for 2015 compared with $2.3 million for 2014. The increase was due to personal costs, public company costs, legal costs and stock-based compensation; sales and marketing expenses of $4.3 million for 2015 compared with $2.1 million in 2014, the increase was due to expenses associated with our expanded sales and marketing organization, clinical outcome and pilot study costs.
Operating loss was $15.1 million in the 12 month ended December 31, 2015 as compared to an operating loss of $5.6 million in the same period last year. The net loss attributable to common stockholders was $17.6 million for the 12 months ended December 31, 2015 or $2.20 per share compared with a net loss attributable to common stockholders of $6.3 million or $16.25 per share for the 12 months ended December 31, 2014. The net loss for the 12 months ended December 31, 2015 included $3.6 million in non-cash charges including a one-time non-cash charge of $2.2 million associated with the debt conversion during our IPO last spring and $1.4 million of stock-based compensation.
Turning to the balance sheet, the Company had cash and cash equivalents of $7.8 million, accounts receivables of approximately $700,000 and inventory of approximately $800,000 as of December 31, 2015. We expect our revenues from rapid diagnostics products to grow in 2016 relative to 2015. We also expect to see an increase in sales of our Acuitas MDRO Gene Test and Acuitas Lighthouse. We will continue to monitor our operating expenses and burn rate very carefully. Investment in sales and marketing, and research and development continue to be important to our growth strategy.
With that, I will turn the call over to Kevin, who will provide an update on the commercial and operational activities. Kevin?
Thanks Tim, good morning everyone. We are continuing to make steady progress with our commercial activities on several fronts. Adoption of our QuickFISH products continues to rebound with the addition of several large and mid-sized hospital accounts since our last call. In addition, we are well into the HARP study which is the large metro area MDRO surveillance program that we have mentioned previously. The study is at 13 top health facilities in the Washington DC metro area. The initial data has been diverse and striking on several fronts.
We look forward to the study’s conclusion in April and the publications that follow. We also recently announced the formation of our expanded Clinical Advisory Board. We have assembled top global experts in the area of infectious disease with a strong emphasis on clinical pharmacology and infectious disease patient management, gene resistance mechanisms, high throughput next generation sequencing and bioinformatics. Our CAB will be invaluable to OpGen as we continue to build our Lighthouse data warehouse and the next generation of highly disruptive rapid testing platforms.
Our 2016 sales and marketing operational plan contains many notable metrics. Of course our first intent is to increase our client base for our rapid diagnostic products beyond the current 100 plus US hospital base. Our sales force has been actively using the results of the Winter Haven study published in the American Journal of Clinical Pathology in January showing significant cost savings using our Staphylococcus assay due to reduced length of stay and a significant reduction in vancomycin usage. In addition, we look to increase the number of systems implementing our MDRO surveillance program. We have several health systems interested in this program and expect to add them and more as we move through the year. To that goal, we are currently expanding our CLIA licensure to all remaining states notably Florida and New York as both have hospital systems that have expressed interest. While we currently have 16 countries ex-US using our rapid FISH based diagnostic, we plan on expansion into several new countries in 2016. To this end, we will have a presence at the ECCMID conference in Amsterdam this April. There we plan to have a demonstration of the automated version of our current QuickFISH products that we anticipate to be released outside of the US in first half of 2017.
To support the growth of this enhanced product release, we are currently in discussions with additional distribution partners globally. Given the scope of our current CLIA lab testing and rapid diagnostic client base, we are well on our way to deploying integrated solutions for both MDRO surveillance and rapid diagnosis in acutely ill patients all grounded and anchored by our Lighthouse data warehouse. Speaking of our database efforts, we recently exhibited our Acuitas Lighthouse products at the HIMSS conference in Las Vegas. HIMSS is the largest health informatics conference in the world focused on IT solutions in human health arena. We were very pleased with the accolades our complete molecular information platform received.
We are often described as having a fully integrated solution to the current challenges based on the hospital-based ID world due to the combination of FDA as well as CLIA lab test along with the full suite of bioinformatics solutions that we possess at OpGen. We'll be announcing the official commercial launch of the Acuitas Lighthouse portal in early Q2. The Lighthouse portal allows all OpGen clients to access and track all of our testing and surveillance results in one user-friendly interface. It’s a very powerful tool to fight the growing MDRO problem and also serves as definitive lab portal for patient specific testing results allowing better clinical decision-making. All of the institutions in the HARP study for example have been using the portal since the study's inception last fall.
In an exciting development last fall, OpGen began a very large health outcomes initiative with one of the nation's most respected integrated health networks. The initial part of this study completed in the first quarter included a retrospective analysis of over 3 million health records to document the scope of the current MDRO crisis we are facing and also demonstrate the value of preemptive knowledge and earlier intervention in patients who become acutely ill with highly resistant pathogens.
In the next phase of the project, we will work with our partner to document the cost and burden of the rising antibiotic resistance crisis in a large integrated health system. Applying painstaking and precise analytics, we are confident we will show the potential for improved patient outcomes and significant health economic savings if OpGen’s current suite of solutions had been in place.
The initiative is anticipated to have multiple phases including prospective phases that will employ real time data generation to manage and guide decisions in settings where MDRO affected patients are found. While we will be discussing and disclosing much more about this major study in the future, I wanted to mention it today, to show the scope of the effort we are deploying to position OpGen to be a leader in reversing the trend of escalating MDRO rate and the subsequent morbidity and mortality along with the staggering costs they cause. As many of you are aware, current projections have the MDRO epidemic if remaining unchecked causing 15 million deaths by 2050, surpassing even cancer. These are alarming projections.
OpGen already has several on-market solutions to help halt the progression of this epidemic and to aid physicians in guiding patient therapy. In addition, we are aggressively building tomorrow’s solutions to fight the problem even more aggressively. With the combination of low-class bioinformatics tools, and unprecedented database and truly disruptive rapid diagnostics, we’re poised to conduct a program globally.
I will now turn the call over to Evan. Evan?
Thank you, Kevin. We are well positioned to become a leader in the transformational shift in infectious disease management to precision medicine solutions. Our emerging molecular information business includes FDA-cleared rapid diagnostics for pathogen ID, rapid tests in development for helping determine antibiotic resistance, Acuitas Lighthouse bioinformatics, and CLIA Lab services and databases for MDRO surveillance and patient management.
As we reflect on a successful 2015, I want to thank all of our customers, employees, collaborators and investors for your hard work, support and business. During the year, we grew product revenue over 135% to $2.7 million. In the fourth quarter, we grew total revenue 18% relative to the prior year. We acquired AdvanDx, a leading rapid molecular diagnostics company. We launched our Acuitas MDRO tests and the Lighthouse MDRO management system. We began the DC HARP MDRO surveillance study in the District of Columbia. And we raised $23 million in capital through our IPO in the Merck GHI investment to support the company’s growth.
An area of disappointment in 2015 was that many of the organizations where we completed successful MDRO surveillance pilots did not fully implement our testing solutions. The client feedback was that while the data was valuable, and the OpGen offerings performed as indicated, they will not take action to implement broad-based MDRO surveillance until they are mandated to do so by government or regulating body or sufficient outcomes and health economics data are available to support implementation.
We are encouraged that the data from the CDC funded DC HARP study and our integrated health system outcomes project that helped catalyze adoption of MDRO screening and surveillance. We will continue our work to pioneer and ultimately capitalize on this important opportunity.
In parallel, we have successfully positioned OpGen to participate in the more than $2 billion rapid diagnostic testing market. We had success with our rapid diagnostic products in 2015 achieving $1.7 million in revenue in the third and fourth quarters.
As noted by Kevin, we are progressing development of our new automated QuickFISH products. Key milestones for this program are FDA submissions after appropriate clinical trials have been completed and the international product release in the first half of 2017.
We have developed an innovative new method for rapid antibiotic resistance analysis. As we entered 2016, we are increasingly optimistic that this groundbreaking work will facilitate the development of new one hour tests for guiding antibiotic decision making.
In summary, OpGen is developing a leading molecular information business. Our rapid diagnostics include proprietary Acuitas and FDA-cleared QuickFISH products, in bioinformatics, we have our Acuitas Lighthouse and customer-facing portals, in our CLIA service lab, we have a complete suite of MDRO surveillance products and we are building our Lighthouse data warehouse. We have a growing network of customers and collaborators and we are proud of the team of professionals we have in place to execute on our plans.
Looking forward, we anticipate continued progress and revenue growth for the company during the year as we build momentum for our rapid diagnostics, bioinformatics, and CLIA lab service offerings.
Thank you for your support and for taking the time to join us today. Operator, we are now ready for questions.
[Operator Instructions] Our first question is from Jason McCarthy with Maxim.
Hi, guys. It sounds like you had a good year. I am really curious about federally mandated MDRO surveillance testing and the feedback that you get from regulators, are they going to move to push hospitals to have to do MDRO surveillance and if so when. And I guess the second part to that question is, if you can move the Acuitas rapid molecular in a couple of the areas, away from - you're not in a CLIA lab setting, you're now in the hospital, does that change the thinking of the administrators of the hospital, will they want to adapt something like that and do their own MDRO surveillance or would they have to be mandated by the federal regulators?
Hey, Jason. This is Kevin. Thanks for the question. And I think that it's really a moving target. I mean, clearly there is momentum. We can't say with any certainty if and when this will be mandated, but what we're seeing is that the government is clearly aware of the escalation and they want to do what they can to prevent that.
With regards to the second part of your question, we're currently turning around these tests in 24 hours. That's a pretty rapid turnaround time and when you're looking at patients who are not acutely ill for surveillance purposes, that is actually pretty adequate. So what we expect is expanded business out of our CLIA lab right here in Gaithersburg.
Okay. Great. And has there been any progress in leveraging discussions with Merck or other big pharma companies for their own anti-microbial discovery platforms in using Lighthouse, and using the databases that OpGen provides and has there been any movement on that front for the company?
Hi, Jason. This is Evan Jones here. Thanks for calling in. You're aware that Merck invested through their GHI investment fund last summer. We've worked closely with them, I'd say, over the last 6 to 8 months on many fronts. We're not in a position to disclose any of that today, but we do see a lot of potential synergies between their interests with their new classes of antibiotics they're bringing to market, what we're doing here at OpGen with our precision medicine solutions. So as you look at 2016, one of the key milestones for us would be to enter into a more detailed strategic partnership type of relationship either with Merck or another large player in the antibiotics and anti-infective space.
Okay. Great. Thanks for taking the questions.
[Operator Instructions] Our next question is from Yi Chen from H.C. Wainwright.
Hi. Thank you for taking my questions. My first question is that, can you give us some color on your expected growth for product sales during 2016, when they're occurring, CLIA lab operation capacity can handle the projected growth?
Yes. We haven't provided guidance for ‘16. We have broadly said that we expect to have product growth in ‘16. We experienced robust product sales in lab services, increases of about 65% in 2015 from 2014. With regards to our CLIA lab, we are clearly capable of handling the projected - our internal projected growth for the next several years.
Okay. Thanks. Second question is given the trend in 2015, can we reasonably expect the operating expenses continue to increase at least a bit in 2016?
Yeah. In terms of looking at the last two quarters, obviously since the acquisition of ADVANDX in the summer, the burn has been pretty consistent at the $4.7 million to $4.8 million. Keep in mind that in each of those quarters, there were kind of one-time charges. Back in the third quarter, it was about $1 million in terms of the acquisition. In this particular quarter, we had some one-time cleanup. So I would anticipate that the expenses will be at that level going into the first two or three quarters of 2016.
Okay. Last question is, can we expect during 2016, additional surveillance network can be implemented for MDO assisted in other regions outside the District of Columbia?
Yeah. Hi. This is Kevin speaking. That's certainly a goal of ours. We look forward as I mentioned to completing that study in April. It clearly gives you a blueprint and insight that one can transfer to other similar metro regions. In addition to that, I mentioned the very large multi-phase study we're doing with an integrated health network, one of the nation's premier integrated health networks. And this is a study again that will provide us with very, very significant data points around clinical utility and health economic outcomes. We believe that that can be leveraged as a tool to move surveillance into other large similar networks in 2016 and beyond.
Okay. Thank you very much.
If there are no further questions, then I'd like to thank all of you for participating in today's conference call. We look forward to updating you on our next call which is anticipated to be in May. Thank you very much.
Ladies and gentlemen, that concludes your conference call for today. We thank you for your participation and ask that you please disconnect your lines.
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